When Public Policy and Medical Science Are Misaligned

Two announcements last week were in startling contrast. One was a scientific development that moves the needle forward, the other a policy announcement that tries to pull it back.

The first development came from Google AI researchers and a published study using a retina scan to assess an individual’s for cardiovascular risk. While still to be validated and done in a larger test population, the study demonstrated that by examining a persons retina, artificial intelligence could apply algorithms that could make determinations about whether or not a person might have high blood pressure or be a candidate for heart attack or stroke. The development of the AI ability still has a way to go, but it is huge development in offering a diagnostic capability that is quick, painless and does not involve drawing and testing blood. It is likely to get better, one would think. It is also part of an overall trend in healthcare – i.e., to simplify the collection and use of data to not only treat patients, but to educate them about their own status. Technology, digital health and artificial intelligence stand to deliver more information into the hands of patients than ever before. The consequence of that will achieve a public health priority – making people aware of their potential medical risks so that they can perhaps avoid or mitigate them through treatment or modification of the status quo. So you are at risk for cardiovascular disease, weight loss might avert the possibility.

But when you engage in a diagnostic screening, you have documented that you may be pre-disposed to a specific condition. Should you develop the condition, if you are insured with a plan that is not required to cover pre-existing conditions, when you then seek treatment for it it could be maintained that you were a person with a pre-existing condition and the treatment would not be covered by your insurance. Fortunately, under the Affordable Care Act, people are not excluded from coverage for a pre-existing condition.

That brings us to the second development. This week Health and Human Services announced a proposed rule that would allow greater leeway for the purchase of short-term healthcare plans. These are plans which do not meet the standards for insurance laid out in the Affordable Care Act – standards which include provision for coverage for pre-existing conditions. Under the current structure, a person may purchase such a plan for a short-term period of three months, under the proposed rule it would expand to twelve months. If it becomes the new norm, assuming people take them up on it, the insurance that is purchased may not cover individuals who have raised their hand by taking a screening test, whether it be Google AI or any other, to assess their risk. Screening potentially becomes a marker for discrimination if one’s insurance policy by insurance in is not required to cover pre-existing condition.

The first development opens the door to expand the options for people in assessing their risk for serious conditions, and perhaps avoiding it through effective prevention efforts. But the second development stands in potential misalignment to that objective. As we are on the cusp of an entire new era in self-monitoring and risk identification, the politics being played out in the healthcare debate may in fact discourage the use and uptake either of the new technologies, or the new insurance option. In the end, we will have to ask ourselves whether public policy should be so mixed with politics that the advancements we make in our medical care are to be undermined by our political scrambling.

About the Author

My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market.

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I am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!

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Eye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.